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Tag Archives: Hologic—

Hologic adds Open Access functionality to Panther Fusion

Nov. 13, 2018—Hologic announced the availability of Open Access functionality for its Panther Fusion system. The enhanced functionality will allow CLIA-certified laboratories to develop laboratory-developed tests to run on the fully automated Fusion platform. Laboratories will be able to run their LDTs simultaneously with commercially available IVD assays, and results will release automatically to laboratory information systems. “We know that ...

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Health Canada approves Panther Fusion

August 2018—Hologic has obtained approval from Health Canada for its Panther Fusion system and Panther Fusion assays for respiratory virus infections. The Panther Fusion module adds the capacity to run PCR assays in addition to tests based on transcription-mediated amplification, the proprietary Hologic chemistry that powers the company’s Aptima brand.

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FDA OKs ThinPrep Integrated Imager

May 1, 2018—Hologic has received FDA premarket approval for its Hologic ThinPrep Integrated Imager. The company says the Integrated Imager combines the power of ThinPrep computer-assisted imaging and the ease of dual slide review into a single, automated microscope. “Approval of the ThinPrep Integrated Imager brings the benefits of ThinPrep automated Pap imaging to small- and mid-sized laboratories in the United ...

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Aptima HBV Quant Assay gets PMA approval

Jan. 30, 2018—Hologic announced the FDA has granted PMA approval for the Aptima HBV Quant Assay for quantitation of hepatitis B viral load on the Panther system. The Aptima HBV Quant assay is the newest addition to the Panther system’s viral load menu, joining the previously approved Aptima HIV-1 Quant Assay and Aptima HCV Quant Dx Assay. The three assays ...

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FDA clears third Panther Fusion assay

Dec. 6, 2017—Hologic announced that it has received FDA 510(k) clearance for its Panther Fusion AdV/hMPV/RV assay running on the Panther Fusion system. The assay detects adenovirus, human metapneumovirus, and rhinovirus. The Panther Fusion assays, which also include the Panther Fusion Flu A/B/RSV assay and the Panther Fusion Paraflu assay, offer a modular approach to syndromic respiratory testing via the ...

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Paraflu assay lands FDA clearance on Panther Fusion

Oct. 30, 2017—Hologic has received 510(k) clearance from the FDA for its Panther Fusion Paraflu assay, a multiplexed assay that runs on the new Panther Fusion system. The Fusion Paraflu assay detects and differentiates parainfluenza viruses 1, 2, 3, and 4. It is the second diagnostic assay available on the Panther Fusion system, complementing the Panther Fusion Flu A/B/RSV assay, ...

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FDA clears Panther Fusion Flu A/B/RSV assay

Oct. 12, 2017—Hologic has received 510(k) clearance from the FDA for its Panther Fusion Flu A/B/RSV assay for use on its Panther Fusion system. The Panther Fusion is available as a full system or as a module that can be attached to existing Panther systems. The Panther Fusion is capable of running polymerase chain reaction assays in addition to tests ...

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